Usgena

Opinion

EMA has issued an opinion on this medicine

ustekinumab

Overview

On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Usgena, intended for the treatment of adults and children with plaque psoriasis, and adults with psoriatic arthritis, Crohn’s disease and ulcerative colitis.

The applicant for this medicinal product is STADA Arzneimittel AG.

Usgena will be available as a 45 mg solution for injection in a vial or pre-filled syringe, a 90 mg solution for injection in one or two pre-filled syringes and a 130 mg concentrate for solution for infusion in a vial. The active substance of Usgena is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the shared p40 protein subunit of interleukin (IL) 12 and 23, thereby preventing them from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. By doing so, ustekinumab prevents  the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Usgena is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorised in the EU on 15 January 2009. Data show that Usgena has comparable quality, safety and efficacy to Stelara.

The full indications are:

Plaque psoriasis

Usgena is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).

Paediatric plaque psoriasis

Usgena is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).

Psoriatic arthritis (PsA)

Usgena, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

Crohn’s Disease

Usgena is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.

Ulcerative colitis

Usgena is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic.

Usgena is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of the conditions for which the medicine is indicated.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Usgena

Adopted Reference Number: EMA/292179/2025

Product details

• Name of medicine:
  Usgena
• Active substance:
  ustekinumab
• International non-proprietary name (INN) or common name:
  ustekinumab
• Therapeutic area (MeSH):
  • Crohn Disease
  • Psoriasis
  • Arthritis, Psoriatic
  • Colitis, Ulcerative
• Anatomical therapeutic chemical (ATC) code:
  L04AC05
• EMA product number:
  EMEA/H/C/006667
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation applicant:
  Stada Arzneimittel AG
• Opinion adopted:
  18/09/2025
• Opinion status:
  Positive